一测多评法同时测定血塞通片中5种皂苷类成分的含量  

Simultaneous Determination of Five Major Saponins in Xuesaitong Tablets by Quantitative Analysis of Multi-components by Single Marker(QAMS)

作　　者：李海亮 张雯洁 金红宇[1] 王莹[1] 马双成[1] Li Hailiang;Zhang Wenjie;Jin Hongyu;Wang Ying;Ma Shuangcheng(National Institutes for Food and Drug Control,Beijing 102629,China;Yunnan Institute for Food and Drug Control,Kunming 650000,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]云南省食品药品监督检验研究院,昆明650000

出　　处：《中国药事》2021年第4期397-405,共9页Chinese Pharmaceutical Affairs

基　　金：国家药典委员会2020年标准提高任务(编号2020Z09)。

摘　　要：目的:建立一测多评法(QAMS)同时测定血塞通片中三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd 5种成分的含量。方法:采用高效液相法,使用Waters Symmetry Shield RP18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水溶液为流动相,梯度洗脱,流速1.3 mL·min^(-1),柱温25℃,检测波长为203 nm。以人参皂苷Re为内标参照物,建立其与三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、人参皂苷Rd的相对校正因子(RCFs);通过一测多评法与外标法(ESM)结果的比较,验证所建立方法的可行性和准确性。结果:5种皂苷在一定范围的浓度内呈良好的线性关系;三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、人参皂苷Rd的相对校正因子分别为0.996、0.856、1.165、0.996;且在不同试验条件下重现性良好(RSD<3.0%)。结论:建立了血塞通片中5种成分的一测多评法,经方法学验证,该法可用于血塞通片中5种皂苷成分的含量测定。Objective: To establish a quantitative analysis of multi-components by single marker(QAMS) for the simultaneous determination of five components(Notoginsenoside R1, Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1, Ginsenoside Rd) in Xuesaitong tablets. Methods: HPLC was performed on Waters Symmetry Shield RP18 column(4.6 mm×250 mm, 5 μm) at 25 ℃, with mobile phase composed of acetonitrile-water at a flow rate of 1.3 mL·min^(-1) in gradient elution mode, and the detection wavelength was set at 203 nm. Using Ginsenoside Re as the internal reference substance, the relative correlation factors(RCFs) of Notoginsenoside R1, Ginsenoside Rg1, Ginsenoside Rb1 and Ginsenoside Rd were calculated. By comparing the results of the external standard method(ESM) and QAMS methods, the feasibility and accuracy of QAMS method were verified. Results: The standard curves of five Saponins had good linear relationship in the ranges of the tested concentrations. The RCFs of Notoginsenoside R1, Ginsenoside Rg1, Ginsenoside Rb1 and Ginsenoside Rd were 0.996, 0.856, 1.165 and 0.996, respectively, and the reproducibility was good under different experimental conditions(RSD<3.0%). Conclusion: The method of QAMS for five Saponins in Xuesaitong tablets was established. The validated method could be used for the assay of 5 Saponins in Xuesaitong tablets.

关 键 词：血塞通片 皂苷类成分 一测多评法 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]